MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number	3MAXC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the basilar artery using a penumbra system 3max reperfusion catheter (3maxc).During the procedure, the 3maxc broke while being pulled through a non-penumbra catheter that had kinked.Therefore, the physician used a new 3maxc and a snare device to retrieve the distal tip of the broken 3maxc.The procedure was then completed using a penumbra system ace68 reperfusion catheter (ace68) and the second 3maxc.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 3maxc was stretched from approximately 147.0 ¿ 160.5 cm from the hub.The device was fractured approximately 150.5 cm from the hub.The distal fractured portion was within the snare device and second returned 3maxc.The total length of the device was approximately 166.0 cm.Conclusions: evaluation of the returned 3maxc confirmed a fracture and revealed the distal shaft was stretched.If the 3maxc is forcefully retracted against resistance, the device may become stretched and fracture.The kinked non-penumbra aspiration catheter likely created the resistance experienced during the procedure.The non-penumbra catheter identified in the complaint was not returned for evaluation.There were no allegations against the second returned 3maxc as it was only used to retrieve the fractured portion of the first 3maxc.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8691901
• Report Number: 3005168196-2019-01139
• Device Sequence Number: 2017053
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2022
• Device Catalogue Number: 3MAXC
• Device Lot Number: F88698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005